depth of necrosis in normal cervical epithelium after 85%
TRANSCRIPT
Depth of Necrosis in Normal Cervical Epithelium After 85% Trichloroacetic Acid (TCA) Application
EXPLANATION FORM FOR STUDY SUBJECT CANDIDATES
Principal Investigator: Laila Nuranna
Professor of Oncology Gynecology
Indonesian University and Cipto Mangungkusumo
Central Hospital
ClinicalTrials.gov identifier : NCT04911075
Unique Protocol ID : 21020134
Version Date : 15/02/2021
Health Study Ethics Committee
FMUI-RSCM FKUI Rumah Sakit Umum Pusat
ETHICS COMMITTEE FOR HEALTH STUDY FKUI-RSCM EXPLANATION FORM FOR STUDY SUBJECT CANDIDATES
I am a part of the Research Team supervised by Laila Nuranna, Professor from the Department of
Gynecology Oncology FKUI-RSCM. We will conduct a research titled Depth of Necrosis in Normal
Cervical Epithelium After 85% Trichloroacetic Acid (TCA) Application.
We would like to inform you about this study and invite you to take part in this study.
You can participate in this study by signing this form. You have the right to withdraw from the study at any time.
You have the right to receive new information from us about the treatments that are being tested. If you refuse to
participate in or withdraw from this study, it will not affect your relationship with us and and the standard of care
provided by this hospital.
If you do not understand any of the statements in this form, please do not hesitate to ask me.
1. Study purposes
To determine the depth of the cervical epithelial cell death process (necrosis) after application with 85
percent TCA solution. TCA is a chemical solution that has long been used for cosmetics (peels) and to treat
skin diseases (genital warts).
2. Participation in this study
If you decide to participate in this study, you will be asked your willingness. This study will involve 40
subjects. In this study, your cervical epithelium will be applied with 85 percent TCA solution. The time of
application is 24 hours before total hysterectomy procedure that had been planned for you. Each procedure
will take approximately 30 minutes.
3. The reason choose you as astudy subject
The selection of this study subject is based on normal cervical epithelium conditions on the visual
inspection of the cervix with acetic acid (VIA) test and would undergo elective total hysterectomy within
24 hours on indication other than cervical pathology.
Health Study Ethics Committee
FMUI-RSCM FKUI Rumah Sakit Umum Pusat
4. Study procedure
4a. Drug Information or Intervention Procedures
1. The doctor will interview you and ask you questions such as your name, age, medical history,
history of using birth control pills, number of children, and method of delivery.
2. Undergo physical examination by a doctor to assess general physical health status and followed by a
cervical examination using a vaginal speculum.
3. Perform VIA test by applying 5% acetic acid to the cervix. If the result is negative, then it will continue
with 85% TCA application.
4. Application of the 85% TCA solution uses a vaginal speculum protected by a condom. 85% TCA
solution will be applied to the entire surface of the cervix and then let stand for 2-3 minutes.
5. After application of 85% TCA solution, you will be monitored for 24 hours in the treatment room,
especially regarding complaints of pain and / or signs of allergies.
4b. Procedures or alternative treatments currently available
This study is conducted on subjects with a normal cervix.
5. Risks, side effects, and management
You may experience mild pain complaint, which can be treated with pain-relieving tablets (paracetamol,
mefenamic acid). Moreover, allergies may also occur which can be treated by administering anti-allergy
tablets (dexamethasone).
6. Benefits
Subjects can perform a VIA test before surgery to assess the condition of the cervix and for early
detection of pre-cancerous lesions.
Participation in this study will contribute to health sciences and national health programs,
especially for cervical cancer prevention programs and the management of pre-cancerous lesions.
7. Compensation
In this study, each subject will be compensated with a sum of money equivalent to Rp. 100.000, - (One
Hundred Thousand Rupiah).
8. Financing
The investigators will cover all study expenses.
Health Study Ethics Committee
FMUI-RSCM FKUI Rumah Sakit Umum Pusat
9. Confidentiality
All study data will be kept confidential in the form of digital files stored on a hard disk with a
secret lock code.
The investigator team has also signed a Study Data Confidentiality Form with a stamp stating that
it will maintain the confidentiality of data and study subjects.
Your name will not appear in publications or presentations of the study results at scientific
meeting or conferences
The study data will be accessible to ethics committes and national regulatory agencies in order to
the study data verification
10. Obligations of study subjects
As a study subject, you should follow the study rules or guidelines as written above. If something is
unclear, you can contact the study team for clarification.
11. Right to refuse and withdraw
You do not have to participate in this study if you do not wish to. You must understand that even if you
agree to participate, you have the right to withdraw from this study. If you refuse to participate or withdraw
from this study, that decision will not affect your relationship with us and will not affect the standard of
care in this hospital. I will allow you at the end of this explanation to be able to consider the decisions that
you will be taken.
12. Post-study access
After this study ends, you will get access to the study results and will be uploaded to the official FKUI
website at the following address: http://study.fk.ui.ac.id
13. Additional information
You are allowed to ask all the things that are not clear about this study. If at any time there are side
effects or need further explanation, you can contact Laila Nuranna, Professor or Dolly Nurdin Lubis,
Ob/Gyn, Phone Number 08122436967, Doctor in The Department of Gynecology Oncology RSCM /
FKUI.
Health Study Ethics Committee
FMUI-RSCM FKUI Rumah Sakit Umum Pusat
AGREEMENT FORM FOR PARTICIPATION IN THIS STUDY
All these explanations have been informed to me and all my questions have been answered by Laila
Nuranna, Professor/ Dolly Nurdin Lubis, Ob/Gyn. I understand that if I need an explanation, I can ask Laila
Nuranna, Professor/ Dolly Nurdin Lubis, Ob/Gyn
Study Information
Principal Investigator : Laila Nuranna, Professor
Study team
Sigit Purbadi, Ob/Gyn (C)
Andi Darma Putra, Ob/Gyn (C)
Tofan Widya Utami, Ob/Gyn (C)
Wawaimuli Arozal, PhD
Primadewi Kusumadjati., PATH (C)
Aria Kekalih, Dr
Dolly Nurdin Lubis, Ob/Gyn
Correspondence
e-mail : [email protected]
HP : 08122436967
KEPK FKUI-RSCM: Salemba Street No 6, Central Jakarta, 10430
Phone: 021 3157008
E-mail: [email protected]
Certificate of Approval (Consent)
I have read all the descriptions of this study. I have been
allowed to ask questions and all my questions have been
answered clearly. I am willing to participate in this
study voluntarily.
____________________________
Name of the subject
____________________________
Subject signature
Date_________________________
Date/month/year
I confirm that participants have been allowed to
ask questions about this study, and all questions
have been answered correctly. I confirm that
consent has been given voluntarily.
____________________________
Name of the investigator
____________________________
Investigator signature
Date_________________________
Date/ month / year